AMASCI 10 mg Film-Coated Tablets

Зміст інструкції

1. What is Amasci and what is it used for
2. What you need to know before taking Amasci
3. How to take Amasci
4. Possible side effects
5. How to store Amasci
6. Package Contents and Other Information

Amasci 10 mg film-coated tablets
Amasci 20 mg film-coated tablets
Escitalopram (as oxalate)
Generic medicine

Read this leaflet carefully before you start taking this medicinebecause it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amasci is and what it is used for
• 2. What you need to know before you take Amasci
• 3. How to take Amasci
• 4. Possible side effects
• 5. How to store Amasci
• 6. Contents of the pack and other information

1. What is Amasci and what is it used for

Amasci contains the active ingredient escitalopram. Amasci belongs to the group of medicines
called selective serotonin reuptake inhibitors (SSRIs) antidepressants. These medicines
act on the serotonergic system of the brain, increasing serotonin levels. Alterations of the
serotonergic system are considered important factors in the development of depression and related disorders.
Amasci contains escitalopram and is used to treat depression (major depressive episodes) and
anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder,
generalized anxiety disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better. Continue taking
Amasci even if it takes some time before you notice an improvement in your
condition.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Amasci

Do not take Amasci

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to a group known as MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).
• If you were born with or have had an episode of heart rhythm disturbance (identified by ECG, an examination performed to assess how your heart is functioning)
• If you are taking medicines for heart rhythm problems or that can affect the heart rhythm (see section 2 "Other medicines and Amasci").

Warnings and precautions
Talk to your doctor or pharmacist before taking Amasci.
Tell your doctor if you have any other conditions or illnesses, as your doctor may need to take this into
account. In particular, tell your doctor:

• If you suffer from epilepsy. Treatment with Amasci should be stopped if you experience seizures for the first time or if the frequency of seizures increases (see also section 4 "Possible side effects").
• If you suffer from impaired liver or kidney function. Your doctor may need to adjust the dose of the medicine.
• If you have diabetes. Treatment with Amasci may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have low levels of sodium in your blood.
• If you are prone to developing bleeding or bruising easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you suffer from or have suffered from heart problems or have recently had a heart attack.
• If you have a low heart rate at rest and/or if you know you have salt deficiencies following prolonged severe diarrhea and vomiting or use diuretics (medicines to urinate).
• If, when standing up, you experience a rapid or irregular heartbeat, fainting, collapsing or dizziness, which may indicate an abnormality in the heart rhythm
• If you have or have had problems with your eyes in the past, such as certain types of glaucoma (increased pressure in the eye).
• Depression or other conditions that are treated with antidepressants. The use of these medicines together with buprenorphine or buprenorphine/naloxone may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Amasci”).

Keep in mind
Some patients with manic-depressive illness may enter a manic phase,
characterized by rapidly changing unusual ideas, inappropriate happiness and excessive physical
activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting still or standing up may occur during the
first few weeks of treatment. Tell your doctor immediately if these symptoms appear.
Medicines such as Amasci (so-called selective serotonin reuptake inhibitors (SSRIs) and
serotonin-noradrenaline (SNRIs)) can cause symptoms of sexual dysfunction (see
section 4). In some cases, persistence of these symptoms has been observed after discontinuation of
treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or committing suicide.
These thoughts may be more frequent at the beginning of treatment with antidepressants, as these
medicines may take some time to work, usually about a couple of
weeks but sometimes even longer.

Youmay be more likely to have thoughts of this kind:

• If you have had suicidal or self-harming thoughts in the past.
• If you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions requiring treatment with an antidepressant. If at any time you haveself-harming or suicidal thoughts, contact your doctor or goimmediately to the hospital. It may be helpful to inform a relativeor close friendabout your depressed state or your

believe that your depression or anxiety is getting worse, or if they are concerned about changes
in your behavior.
Use in children and adolescents
Normally Amasci should not be taken by children and adolescents under the age of 18 years.
You should also know that patients under the age of 18 who take this type of medicine,
have an increased risk of side effects such as suicide attempts, suicidal thoughts
and hostility (mainly aggression, oppositional behavior and anger). Nevertheless, the
doctor may prescribe Amasci to patients under the age of 18 if he believes this is the
best solution for them. If the doctor has prescribed Amasci to a patient under the age of 18 and
you would like clarification, return to the doctor. You should tell the doctor if any of the symptoms
reported above appear or worsen when patients under the age of 18 are
taking Amasci. In addition, the effects on long-term safety of Amasci on growth,
maturation and cognitive and behavioral development have not yet been demonstrated in this age group.

Other medicines and Amasci
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazide, isocarboxazide, nialamide and tranylcypromine as the active ingredient. If you have taken any of these medicines, you must wait 14 days before starting treatment with Amasci. After stopping treatment with Amasci, 7 days must pass before taking any of these medicines.
• “Reversible MAO-A selective inhibitors" containing moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors", containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of side effects;
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used to fight severe pain). These medicines increase the risk of side effects.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used for the treatment of fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These can cause an increase in the levels of escitalopram in the blood.
• St John's Wort ( hypericum perforatum): a herbal product used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce blood density, also called anticoagulants). These can increase the tendency to bleed.
• Warfarin, dipyridamole and phenprocoumone (medicines used to reduce blood density, also called anticoagulants). The doctor will probably check the coagulation time at the beginning and end of treatment with Amasci, to verify that your anticoagulant dose is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used in the treatment of severe pain), due to the possible risk of a reduced seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of a reduced seizure threshold.
• Flecainide, propafenone and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). An adjustment of the escitalopram dose may be necessary.
• Medicines that increase potassium or magnesium levels in the blood, as these conditions increase the risk of potentially life-threatening heart rhythm disturbances.
• A ntidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines may interact with buprenorphine or buprenorphine/naloxone and may manifest symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased muscle contraction, fever above 38 °C. Contact your doctor if you experience these symptoms. Do not take escitalopram if you are taking medicines for heart rhythm problems or that can affect the heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatments, in particular halofantrine), some antihistamines (such as astemizole, mizolastine). If you have any further doubts, consult your doctor.

Amasci with food, drinks and alcohol
Amasci can be taken with or without food (see section 3 “How to take Escitalopram”).
As with many medicines, the combination of Amasci and alcohol is not recommended, even though
escitalopram is not expected to interact with alcohol.

Pregnancy, breastfeeding and fertility,
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
Do not take Amasci if you are pregnant and breastfeeding with breast milk, unless your
doctor has discussed the risks and benefits of treatment with you.
Pregnancy
If you take Amasci near the end of pregnancy, there may be an increased risk of
heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders
(easy bleeding). Inform your treating doctor or midwife that you are taking
Amasci, so they can advise you on what to do.
If you take Amasci in the last trimester of pregnancy, you should know that the newborn may
experience the following effects: difficulty breathing, bluish skin discoloration, convulsions, instability
of body temperature, difficulty feeding, vomiting, hypoglycemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, nervousness, irritability, lethargy, crying continuously,
falling asleep and difficulty sleeping. If the newborn experiences any of these symptoms, contact
your doctor immediately.
Make sure to inform the midwife and/or doctor that you are taking Amasci. If taken during pregnancy,
especially in the last 3 months of gestation, medicines such as Amasci can increase the risk
of developing a serious condition in newborns, called persistent pulmonary hypertension in the
neonate ( persistent pulmonary hypertension in neonates- PPHN), which makes the baby breathe
faster and makes the skin appear bluish. These symptoms usually appear within the
first 24 hours after the baby is born. If this happens, contact the midwife and/or
doctor immediately.
If taken during pregnancy, Amasci should never be stopped abruptly.
It is expected that Amasci will be excreted in breast milk.
Citalopram, a medicine similar to escitalopram, in studies on animals, has shown to reduce
the quality of sperm. Theoretically, this may affect fertility, but the impact on human fertility has not
yet been observed.

Driving and using machines
It is advisable not to drive vehicles or use machinery until you know how Amasci affects
you.

This medicine contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take Amasci

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Adults

Depression
The normally recommended dose of Amasci is 10 mg once a day. The dose may be
increased by your doctor up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Amasci is 5 mg once a day for the first week, before increasing to
10 mg per day. The dose may be further increased by your doctor up to a maximum of 20 mg
per day.

Social anxiety disorder
The normally recommended dose of Amasci is 10 mg once a day. Your doctor may reduce the
dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to
the medicine.

Generalized anxiety disorder
The normally recommended dose of Amasci is 10 mg once a day. The dose may be
increased by your doctor up to a maximum of 20 mg per day.

Obsessive compulsive disorder
The normally recommended dose of Amasci is 10 mg once a day. The dose may be
increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended starting dose of Amasci is 5 mg once a day. The dose may be increased
by your doctor up to 10 mg per day.

Use in children and adolescents
Amasci should not normally be given to children and adolescents. For further
information see section 2 “Warnings and precautions”.
How to take the tablets
You can take Amasci with or without food. Swallow the tablet with a little water. Do not chew it,
as the taste is bitter.
If necessary, you can divide the tablets by placing them on a flat surface with the score line
facing upwards. The tablets can be broken by pressing down on the edges of the two
halves of the tablet, using both index fingers as shown in the drawing.

Duration of treatment
It may take a couple of weeks before you notice any improvement. Continue to
take Amasci even if it takes some time before you feel an improvement in your
condition.
Do not change the dose of the medicine without first consulting your doctor.
Continue to take Amasci for as long as your doctor has recommended. If you stop the
treatment too soon, the symptoms may return. It is recommended to continue treatment for
at least 6 months after you feel better again.

If you take more Amasci than you should
If you take a dose of Amasci higher than that prescribed, you should contact your doctor or go
immediately to the Emergency Room of the nearest hospital. Do this even if you have
no signs of discomfort. Some of the symptoms of overdose may be dizziness, tremor, agitation,
convulsions, coma, nausea, vomiting, altered heart rhythm, decreased blood pressure and changes in
electrolyte balance. Bring the box/container of Amasci with you when you go to the doctor or hospital.

If you forget to take Amasci
Do not take a double dose to make up for a missed dose. If you forget to take a
dose and remember before bedtime, take it immediately. Continue taking as usual the next day. If instead you remember during the night or the next day, skip the missed dose and
continue with the normal dosage.

If you stop taking Amasci
Do not stop taking Amasci until your doctor tells you to. When you have completed the
treatment, it is generally advisable to gradually reduce the dose of Amasci over a few
weeks.
When you stop taking Amasci, especially if you stop it suddenly, you may experience
withdrawal symptoms, which are common when treatment with Amasci is stopped. The risk is
greater if you have taken Amasci for a long time or in high doses or if the dose is reduced too
quickly. Most people find the symptoms mild and that they disappear
spontaneously within two weeks. However, in some patients, withdrawal symptoms may be
severe or may persist over time (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking Amasci, tell your doctor, who may ask you
to resume treatment and continue reducing the doses more gradually.
Withdrawal symptoms include: dizziness (feeling unstable or off balance), tingling sensation, burning (less commonly) and shock-like sensation, even in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), anxiety, headache, malaise
(nausea), sweating (including night sweats), feeling restless or agitated, tremor
(shaking), feeling confused or disoriented, feeling emotional or irritable,
diarrhea (loose stools), visual disturbances, heart rhythm disturbances (palpitations).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. Please be aware
that many of the side effects can also be symptoms of your illness and, therefore,
will decrease as you start to feel better.

If you experience any of the following symptoms you should contact your doctor or go to
hospital immediately:
Uncommon (may affect up to 1 in 100 people):

• Abnormal bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000):

• Swelling of the skin, tongue, lips, throat or face, urticaria or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremor and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome. Not known (frequency cannot be estimated from available data)
• Difficulty with urination.
• Convulsions (seizures), see also paragraph 2 "Warnings and precautions".
• Yellowing of the skin and whites of the eyes are signs of impaired liver function/hepatitis.
• Rapid, irregular heartbeat, feeling faint, which may be symptoms of a potentially life-threatening condition, known as Torsades de Pointes.
• Thoughts of self-harm or suicide. See also paragraph 2 “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to those listed above, the following side effects have also been reported:
Very common (may affect more than 1 in 10 people):

• nausea
• headache

Common (may affect up to 1 in 10 people):

• blocked or runny nose (sinusitis)
• decreased or increased appetite
• anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling of the skin
• diarrhoea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain (arthralgia and myalgia)
• sexual dysfunction (delayed ejaculation, problems with erection, decreased sexual drive and women may have difficulty reaching orgasm)
• fatigue, fever
• weight gain

Uncommon (may affect up to 1 in 100):

• urticaria, skin rash, itching
• teeth grinding, agitation, nervousness, panic attacks, confusion
• disturbed sleep, altered taste, fainting (syncope)
• dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• hair loss
• increased menstrual flow
• irregular menstrual cycle
• weight loss
• fast heartbeat
• swelling of arms or legs
• nosebleeds

Rare (may affect up to 1 in 1000):

• aggression, depersonalization, hallucinations
• slow heartbeat

Not known (frequency cannot be estimated from available data):

• decreased level of sodium in the blood (symptoms are feeling unwell with muscle weakness or confusion)
• dizziness when getting up from a sitting or lying position, due to a drop in blood pressure (orthostatic hypotension)
• changes in liver function values (increased amount of liver enzymes in the blood)
• movement disorders (involuntary muscle movements)
• painful erections (priapism)
• signs of abnormal bleeding, e.g. of the skin and mucous membranes (ecchymosis)
• increased production of a hormone called ADH, which causes fluid retention and dilution of the blood, with resulting reduction in sodium levels (inappropriate ADH secretion)
• secretion of milk in men and in women who are not breastfeeding
• mania
• an increased risk of bone fractures has been observed in patients taking this type of medicine.
• alteration of the heart rhythm (called "prolongation of the QT interval", assessed by ECG, which measures the electrical activity of the heart)
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see paragraph 2, Pregnancy, breastfeeding and fertility, for further information.

In addition, a number of side effects are known for drugs that work like escitalopram (active
ingredient of Amasci). These are:

• restlessness (akathisia)
• loss of appetite

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Amasci

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or the packaging after
Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Amasci contains
The active ingredient is escitalopram. Each Amasci tablet contains 10 mg or 20 mg of escitalopram
(as oxalate).
The other ingredients are

Core: lactose monohydrate, anhydrous colloidal silica, sodium croscarmellose, sodium carboxymethylcellulose,
propyl gallate, talc and magnesium stearate.

Coating:HPMC 2910/Hypromellose 6cP, titanium dioxide (E 171) and macrogol 400.

Description of the appearance of Amasci and package contents
Amasci is available as film-coated tablets of 10 mg and 20 mg. The tablets are described
below.
10 mg: film-coated tablet, biconvex, round, from white to off-white in color, with "ML
60" imprinted on one side, a score line on the opposite side and notches on both sides
of the score line (approximate size: 7.14 mm).
20 mg: film-coated tablet, biconvex, round, from white to off-white in color, with "ML
61" imprinted on one side, a score line on the opposite side and notches on both sides of the
score line (approximate size: 9.5 mm).
Amasci tablets are available in blister packs of cold-formed laminated film in OPA
25µ / aluminum 45µ / PVC 60 µ - aluminum foil.
Packs: 28, 56 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ecupharma S.r.l. - Via Mazzini 20 - 20123 Milan (Italy).

Manufacturers
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue, Wynyard,
Billingham, TS22 5TB
United Kingdom
IDIFARMA DESARROLLO FARMACÉUTICO, S.L.
Poligono Mocholi
C/Noain, 1
31110 Noain (Navarra)
Spain